A NEW VALIDATED RP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF SIMEPREVIR AND SOFOSBUVIR IN PHARMACEUTICAL DOSAGE FORM

2016-05-05T19-36-43Z
Source: Indo American Journal of Pharmaceutical Research
B. Raj Kumar*, Dr. K. V.Subrahmanyam.
Simeprevir is indicated in patients with hepatitis C virus (HCV) genotype 1 for the treatment of chronic hepatitis as a combination therapy, which includes peg interferon alfa and ribavirin. Simeprevir is a protease inhibitor for HCV NS3/4A protease, which is required for replication of the virus. Simeprevir functions as a direct-acting antiviral agent because it inhibits hepatitis C viral replication by binding to and inhibiting the protease, hepatitis C virus (HCV) NS3/4A. After oral administration, simeprevir reaches its maximum plasma concentrations in 4-6 hours. SOVALDI is the brand name for sofosbuvir, a nucleotide analog inhibitor of HCV NS5B polymerase. The IUPAC name for sofosbuvir is (S)-Isopropyl 2-((S)-(((2R, 3R, 4R, 5R)-5-(2, 4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)-(phenoxy)phosphorylamino)propanoate. It has a molecular formula of C22H29FN3O9P and a molecular weight of 529.45. is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen A novel reversed phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative determination of Simeprevir and sobosuvir in active pharmaceutical ingredients and in its Pharmaceutical dosage form by using symmetry X-Terra C18 as stationary phase and a mobile phase containing a mixture of Acetonitrile: Water (75:25% v/v). The flow rate was 1.0 ml/min and effluent was monitored at 253nm and a peak eluted at .090, 5.289 ±0.02min and column oven temperature was maintained ambient. Calibration curve was plotted with a range from 0-30 μg/ml. The developed RP-HPLC method was validated according to the current International Conference on Harmonization (ICH) guidelines for specificity, LOD, LOQ, linearity, accuracy, precision, intermediate precision and robustness. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine analysis of Simeprevir & Sofosbuvir in bulk drug and in its pharmaceutical dosage form.


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